REMS For Mavacamten Could Involve Additional Monitoring, BMS Says
User Fee Delayed; Potential For Systolic Dysfunction Needs Watching
The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.
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The REDWOOD-HCM study showed early, sustained efficacy and no serious adverse events with a drug Cytokinetics designed to be superior to mavacamten, a drug it spun out via BMS-acquired MyoKardia.
Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.
Paying $13.1bn for MyoKardia and its potential first-in-class HCM drug, BMS sees a blockbuster sales opportunity that it will grow gradually. MyoKardia team will be absorbed into BMS, Caforio says.